FDA recall Z-0845-2018

Toshiba American Medical Systems Inc · Class II · device

Product

INFX-8000H Fluoroscopic X-Ray Systems

Reason for recall

During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

Distribution

United States

Key facts

Status: Terminated
Initiation date: 2017-12-29
Report date: 2018-03-14
Termination date: 2023-11-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tustin, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0845-2018